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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01638000
Other study ID # 178-EC-001
Secondary ID 2011-005713-37
Status Completed
Phase Phase 3
First received July 9, 2012
Last updated November 20, 2017
Start date June 12, 2012
Est. completion date April 24, 2013

Study information

Verified date November 2017
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.


Recruitment information / eligibility

Status Completed
Enrollment 1887
Est. completion date April 24, 2013
Est. primary completion date April 24, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject is willing and able to complete the micturition diary and questionnaires correctly

- Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months

- Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit

Exclusion Criteria:

- Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control

- Subject has neurogenic bladder

- Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test)

- Subject has an indwelling catheter or practices intermittent self-catheterization

- Subject has diabetic neuropathy

- Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs

- Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated

- The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening

- Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening)

- Subject has moderate to severe hepatic impairment

- Subject has severe renal impairment or end stage renal disease

- Subject has severe uncontrolled hypertension

- Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval

- Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients

- Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening

- Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives

- Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria

- Subject's last antimuscarinic treatment was solifenacin

Study Design


Intervention

Drug:
Mirabegron
oral tablet
Solifenacin succinate
oral tablet

Locations

Country Name City State
Armenia Site: 37401 Yerevan
Armenia Site: 37402 Yerevan
Armenia Site: 37403 Yerevan
Armenia Site: 37404 Yerevan
Armenia Site: 37406 Yerevan
Austria Site: 43006 Baden
Austria Site: 43014 Graz
Austria Site: 43015 Innsbruck
Austria Site: 43013 Linz
Austria Site: 43005 Oberwart
Austria Site: 43002 Vienna
Austria Site: 43011 Vienna
Austria Site: 43003 Wels
Belarus Site: 37501 Minsk
Belarus Site: 37502 Minsk
Belarus Site: 37504 Vitebsk
Belgium Site: 32006 Brussels
Belgium Site: 32008 Deurne
Belgium Site: 32001 Edegem
Belgium Site: 32004 Gent
Belgium Site: 32007 Leuven
Belgium Site: 32005 Liege
Bulgaria Site: 35902 Burgas
Bulgaria Site: 35909 Haskovo
Bulgaria Site: 35901 Lovech
Bulgaria Site: 35905 Plovdiv
Bulgaria Site: 35903 Sofia
Bulgaria Site: 35906 Sofia
Bulgaria Site: 35908 Sofia
Canada Site: 10010 Abbotsford
Canada Site: 10011 Barrie
Canada Site: 10001 Bathurst
Canada Site: 10003 Brampton
Canada Site: 10005 Brantford
Canada Site: 10007 Kingston
Canada Site: 10002 Montreal
Canada Site: 10009 Sherbrooke
Canada Site: 10004 Toronto
Canada Site: 10008 Victoria
Czechia Site: 42004 Bohumin
Czechia Site: 42003 Brno
Czechia Site: 42001 Hradec Kralove
Czechia Site: 42002 Jihlava
Czechia Site: 42006 Plzen-Lochotin
Czechia Site: 42008 Prague
Czechia Site: 42005 Prague 1
Czechia Site: 42007 Prague 4
Denmark Site: 45002 Aalborg
Denmark Site: 45001 Aarhus N
Denmark Site: 45005 Frederiksbjerg
Denmark Site: 45004 Hvidovre
Denmark Site: 45003 Odense C
Finland Site: 35802 Jyvaskyla
Finland Site: 35801 Oulu
Finland Site: 35804 Tampere
France Site: 33010 Angers
France Site: 33007 Colmar Cedex
France Site: 33011 Dijon
France Site: 33002 Marseille
France Site: 33006 Marseille
France Site: 33013 Nimes
France Site: 33004 Orleans Cedex 2
France Site: 33001 Paris Cedex 20
France Site: 33005 Paris Cedex 20
France Site: 33003 Rouen
France Site: 33014 Suresnes Cedex
France Site: 33017 Tours
France Site: 33015 Valence
Georgia Site: 99501 Tbilisi
Georgia Site: 99502 Tbilisi
Georgia Site: 99503 Tbilisi
Germany Site: 49006 Bad Ems
Germany Site: 49009 Halle Saale
Greece Site: 30005 Alexandroupoli
Greece Site: 30001 Athens
Greece Site: 30007 Athens
Greece Site: 30009 Athens
Greece Site: 30006 Herakleion
Greece Site: 30008 Larisa
Greece Site: 30004 Patras
Greece Site: 30002 Thessaloniki
Greece Site: 30010 Thessaloniki
Hungary Site: 36003 Budapest
Hungary Site: 36004 Budapest
Hungary Site: 36005 Csongrad
Hungary Site: 36006 Nyiregyhaza
Hungary Site: 36001 Salgotarjan
Hungary Site: 36002 Szekszard
Ireland Site: 35304 Cork
Ireland Site: 35301 Dublin
Ireland Site: 35302 Dublin
Ireland Site: 35306 Dublin
Ireland Site: 35303 Tralee
Ireland Site: 35305 Waterford
Italy Site: 39001 Avellino
Italy Site: 39005 Catanzaro
Italy Site: 39003 Cinisello Balsamo
Italy Site: 39002 Florence
Italy Site: 39008 Milan
Italy Site: 39010 Pavia
Italy Site: 39006 Perugia
Italy Site: 39007 Treviglio
Kazakhstan Site: 77705 Almaty
Kazakhstan Site: 77706 Almaty
Kazakhstan Site: 77702 Astana
Kazakhstan Site: 77703 Astana
Latvia Site: 37103 Liepaja
Latvia Site: 37101 Riga
Latvia Site: 37102 Riga
Lebanon Site: 96103 Achrafieh
Lebanon Site: 96102 Jbeil
Lithuania Site: 37001 Kaunas
Lithuania Site: 37003 Vilnius
Netherlands Site: 31010 Amsterdam
Netherlands Site: 31005 Eindhoven
Netherlands Site: 31004 Enschede
Netherlands Site: 31007 Nijmegen
Netherlands Site: 31001 Tilburg
Netherlands Site: 31008 Utrecht
Netherlands Site: 31006 Zwolle
Norway Site: 47002 Hamar
Norway Site: 47001 Tonsberg
Norway Site: 47005 Trondheim
Poland Site: 48007 Kolbuszowa Dolna
Poland Site: 48006 Krakow
Poland Site: 48001 Lublin
Poland Site: 48004 Piaseczno
Poland Site: 48003 Warsaw
Poland Site: 48005 Wroclaw
Portugal Site: 35104 Lisbon
Portugal Site: 35105 Lisbon
Portugal Site: 35102 Matosinhos
Portugal Site: 35103 Porto
Portugal Site: 35101 Setubal
Russian Federation Site: 70001 Moscow
Russian Federation Site: 70002 Moscow
Russian Federation Site: 70003 Moscow
Russian Federation Site: 70005 Moscow
Russian Federation Site: 70006 Moscow
Russian Federation Site: 70007 Moscow
Russian Federation Site: 70008 Moscow
Russian Federation Site: 70011 Moscow
Russian Federation Site: 70009 Saint Petersburg
Russian Federation Site: 70010 Saint Petersburg
Russian Federation Site: 70012 Saint Petersburg
Russian Federation Site: 70013 Saint Petersburg
Russian Federation Site: 70004 St. Petersburg
Slovakia Site: 42104 Galanta
Slovakia Site: 42106 Martin
Slovakia Site: 42103 Piestany
Slovakia Site: 42101 Poprad
Slovakia Site: 42105 Trencin
Slovakia Site: 42102 Zilina
Slovenia Site: 38603 Ljubljana
Slovenia Site: 38604 Ljubljana
Slovenia Site: 38601 Maribor
Slovenia Site: 38602 Maribor
Slovenia Site: 38606 Novo Mesto
Spain Site: 34001 Barcelona
Spain Site: 34002 Barcelona
Spain Site: 34009 Bilbao
Spain Site: 34003 Madrid
Spain Site: 34004 Madrid
Spain Site: 34005 Madrid
Spain Site: 34011 Mendaro
Spain Site: 34013 Murcia
Spain Site: 34010 San Sebastian
Spain Site: 34014 Sevilla
Spain Site: 34012 Valencia
Sweden Site: 46007 Gothenburg
Sweden Site: 46004 Halmstad
Sweden Site: 46005 Karlshamn
Sweden Site: 46003 Norrtalje
Sweden Site: 46001 Stockholm
Sweden Site: 46002 Stockholm
Sweden Site: 46006 Uppsala
Switzerland Site: 41001 Frauenfeld
Switzerland Site: 41003 Zurich
Turkey Site: 90003 Ankara
Turkey Site: 90005 Ankara
Turkey Site: 90011 Denizli
Turkey Site: 90007 Diyarbakir
Turkey Site: 90004 Istanbul
Turkey Site: 90001 Izmir
Turkey Site: 90008 Izmir
Turkey Site: 90009 Manisa
Turkey Site: 90010 Sivas
Ukraine Site: 38007 Chernivtsi
Ukraine Site: 38004 Dnepropetrovsk
Ukraine Site: 38001 Kharkov
Ukraine Site: 38002 Kiev
Ukraine Site: 38003 Lviv
United Kingdom Site: 44027 Aberdeen
United Kingdom Site: 44029 Birmingham
United Kingdom Site: 44025 Cambridge
United Kingdom Site: 44030 Chichester
United Kingdom Site: 44028 Croydon
United Kingdom Site: 44003 Devon
United Kingdom Site: 44001 Edgbaston
United Kingdom Site: 44011 Glasgow
United Kingdom Site: 44023 Harrow
United Kingdom Site: 44006 Kent
United Kingdom Site: 44012 Leeds
United Kingdom Site: 44019 Leicester
United Kingdom Site: 44008 Liverpool
United Kingdom Site: 44010 London
United Kingdom Site: 44017 London
United Kingdom Site: 44013 Newcastle upon Tyne
United Kingdom Site: 44022 Northwood
United Kingdom Site: 44021 Nottingham
United Kingdom Site: 44009 Plymouth
United Kingdom Site: 44007 Reading
United Kingdom Site: 44005 Sheffield
United Kingdom Site: 44020 Southampton
United Kingdom Site: 44026 Taunton
United Kingdom Site: 44002 West Yorkshire
United Kingdom Site: 44024 West Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Europe Ltd.

Countries where clinical trial is conducted

Armenia,  Austria,  Belarus,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  Finland,  France,  Georgia,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Kazakhstan,  Latvia,  Lebanon,  Lithuania,  Netherlands,  Norway,  Poland,  Portugal,  Russian Federation,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. Baseline and final visit (up to Week 12)
Secondary Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder). From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)
Secondary Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours Baseline and Week 4, Week 8, Week 12
Secondary Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. Week 4, Week 8, Week 12
Secondary Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. Baseline and Week 4, Week 8, Week 12
Secondary Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. Week 4, Week 8, Week 12
Secondary Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. Baseline and Week 4, Week 8, Week 12
Secondary Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. Baseline and Week 4, Week 8, Week 12
Secondary Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence. Baseline and Week 4, Week 8, Week 12
Secondary Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. Week 4, Week 8, Week 12
Secondary Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. Baseline and Week 4, Week 8 , Week 12
Secondary Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit A nocturia episode is defined as waking at night =1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit. Week 4, Week 8, Week 12
Secondary Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment A nocturia episode is defined as waking at night =1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period. Baseline and Week 4, Week 8, Week 12
Secondary Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit A responder is defined as a participant who has =8 micturitions at baseline and has <8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is <0. Week 4, Week 8, Week 12
Secondary Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit. Week 4, Week 8, Week 12
Secondary Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit. Week 4, Week 8, Week 12
Secondary Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 4
Secondary Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 4
Secondary Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 4
Secondary Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 4
Secondary Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 4
Secondary Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 8
Secondary Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 8
Secondary Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 8
Secondary Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 8
Secondary Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 8
Secondary Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 12
Secondary Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 12
Secondary Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 12
Secondary Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 12
Secondary Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and Week 12
Secondary Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and final visit (up to Week 12)
Secondary Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and final visit (up to Week 12)
Secondary Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and final visit (up to Week 12)
Secondary Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and final visit (up to Week 12)
Secondary Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]). Baseline and final visit (up to Week 12)
Secondary Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement. Baseline and Week 4, Week 8, Week 12
Secondary Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement. Baseline and Week 4, Week 8, Week 12
Secondary Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. Baseline and Week 4, Week 8, Week 12
Secondary Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS) The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question "Are you satisfied with your treatment?" and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely). Baseline and Week 12
Secondary Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question "How satisfied were you with your treatment?" with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied). Baseline and Week 12
Secondary Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: = 10 Points Improvement in OAB-q at Week 12 and Final Visit A responder is defined as a participant with =10 points improvement in symptom bother from baseline. Baseline to Week 12
Secondary Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: =10 Points Improvement in OAB-q at Week 12 and Final Visit A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline. Baseline to Week 12
Secondary Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: =1, =2, =3, =4, =5, and 6-point Improvement From Baseline to Week 12 A responder is defined as a participant with =1, =2, =3, =4, =5 or 6-point improvement from baseline in TS-Likert scale. Baseline to Week 12
Secondary Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: =1, =2, =3, =4, =5, and 6-point Improvement From Baseline to Final Visit A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale. Baseline to final visit (up to Week 12)
Secondary Percentage of Participants With Improvement in PPBC: =1 Point Improvement at Week 12 and Final Visit A responder is defined as a participant with =1 point improvement in PPBC from baseline. Baseline to Week 12
Secondary Percentage of Participants With Major Improvement in PPBC: =2 Point Improvement at Week 12 and Final Visit A responder is defined as a participant with =2 point improvement in PPBC from baseline. Baseline to Week 12
See also
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